Cyberonics NCP NeuroCybernetic Prosthesis is approvable with conditions, FDA panel recommends
This article was originally published in The Gray Sheet
Executive Summary
CYBERONICS NCP NEUROCYBERNETIC PROSTHESIS APPROVABLE WITH CONDITIONS, FDA's Neurological Devices Panel recommended in a 9-0 vote at a June 27 meeting in Rockville, Maryland. The panel supported use of the device in adults and adolescents over 12 years of age for treatment of seizures. NCP consists of an implantable generator connected via leads to the left vagus nerve and uses mild electrical signals to prevent or stop seizures.